A Phase 3, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Lomitapide in Japanese Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Concurrent Lipid-Lowering Therapy
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 28 Sep 2016
At a glance
- Drugs Lomitapide (Primary)
- Indications Hyperlipoproteinaemia type II
- Focus Registrational; Therapeutic Use
- Sponsors Aegerion Pharmaceuticals
- 28 Sep 2016 According to Aegerion Pharmaceuticals media release, based upon the data of this trial, Japan's Ministry of Health, Labor & Welfare (MHLW) has approved JUXTAPID for patients with homozygous familial hypercholesterolemia (HoFH).
- 11 Jan 2016 According to an Aegerion Pharmaceuticals media release, the company has submitted a New Drug Application to the Ministry of Health, Labour and Welfare (MHLW) for marketing approval of JUXTAPID for the treatment of homozygous familial hypercholesterolemia (HoFH) in Japan.
- 17 Jun 2015 Planned End Date changed from 1 Jul 2015 to 1 Nov 2015 as reported by ClinicalTrials.gov record.